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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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IntraSpin Fuse 110v
BIOHORIZONS IMPLANT SYSTEMS, INC
BFUSE110Z
In Commercial Distribution

  • 00847236015831 ()


  • Haematological concentrate system
IntraSpin Centrifuge, 220 volts
BIOHORIZONS IMPLANT SYSTEMS, INC
IS220Z
In Commercial Distribution

  • 00847236015824 ()


  • Haematological concentrate system
Automated Blood Collection System
TERUMO BCT, INC.
81001
In Commercial Distribution

  • 05020583810013 ()


  • Apheresis system
Refurbished COBE® Spectra Apheresis System
TERUMO BCT, INC.
71900
Not in Commercial Distribution

  • 05020583719002 ()


  • Blood transfer set
SCD®-IIB Sterile Tubing Welder
TERUMO BCT, INC.
62002
In Commercial Distribution

  • 05020583620025 ()


  • Package sealing unit
3-Ncc947 Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC947
In Commercial Distribution

  • 05020583300064 ()


  • Package sealing unit
Weld Integrity Test Kit
TERUMO BCT, INC.
3NCC945
In Commercial Distribution

  • 05020583300040 ()


  • Package sealing unit
Sterile Tubing Welder
TERUMO BCT, INC.
3MESC203A
In Commercial Distribution

  • 05020583300033 ()


  • Package sealing unit
SCD II Final Assembly
TERUMO BCT, INC.
3NCC986
In Commercial Distribution

  • 05020583300026 ()


  • Package sealing unit
TOMEs Terumo Operational Medical Equipment Software Version 7.3
TERUMO BCT, INC.
11401
In Commercial Distribution

  • 05020583114012 ()
11401

  • Blood bank information system application software
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